Background: The standard treatment for locally advanced borderline-resectable esophageal squamous cell carcinoma (BR-ESCC) is still debated owing to insufficient evidence from clinical trials. An increasing number of clinical studies focus on investigating the use of immunotherapy in the treatment of oesophageal cancer. This phase II trial (NEOCRTEC-2001) aimed to assess the safety and efficacy of sintilimab in combination with cisplatin and nab-paclitaxel induction immunochemotherapy followed by surgery for BR-ESCC.
Methods: The NEOCRTEC2001 trial was a single-centre, open-label, nonrandomized, phase II study. Patients diagnosed with BR-ESCC were enrolled in the study and initially received 2–4 courses of induction immunochemotherapy at first. The subsequent treatment, surgery or definitive chemoradiotherapy, was determined based on reassessment by MDT. The primary endpoint of the study was the R0 resection rate.
Results: From September 2020 to June 2024, a total of 50 eligible patients diagnosed with BR-ESCC were enrolled. All eligible patients underwent induction immunochemotherapy as the initial treatment. After induction immunochemotherapy, 35 of 50 patients (70.0%) were considered resectable, and 29 patients (58.0%) underwent surgery. R0 resection was achieved in 28 patients (56.0%, 95% CI, 41.4–69.1%), and 9 patients (18.0%) achieved pathological complete response. The median follow-up time of all patients was 29.43 months. Patients in the R0 resection group demonstrated significantly superior overall survival (OS) and progression-free survival (PFS) compared to those in the non-R0 group (OS: not reached vs. 19.84 months; HR .25; 95%CI .08–.79, p = .001; PFS: not reached vs. 19.82 months; HR .30; 95%CI .10–.90, p = .006).
Conclusions: The regimen under investigation did not exhibit the anticipated statistical benefit in enhancing surgical conversion rates for BR-ESCC. Nevertheless, the treatment strategy of induction immunochemotherapy followed by surgery resulted in significant tumour downstaging and a significant pathological complete response rate. Patients who achieved R0 resection exhibited improved survival outcomes.
Trial registration: The study was registered at ClinicalTrials.gov (NCT04548440)
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2026 The Author(s). Clinical and Translational Medicine published by John Wiley & Sons Australia, Ltd on behalf of Shanghai Institute of Clinical Bioinformatics.
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